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Phamacokinetic and Pharmacodynamic Study of Ramosetron in Chemotherapy Induced Nasea and Vomiting

Primary Purpose

Colon Cancer

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Ramosetron 0.3mg

Ramosetron 0.45mg

Ramosetron 0.6mg

About this trial

This is an interventional supportive care trial for Colon Cancer focused on measuring chemotherapy induced nausea vomiting

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients who recevied moderate emetogenic chemotherapy
Age between 18-75
ECOG PS 0-2
Adequate organ fuction including bone marrow, liver and kidney

Exclusion Criteria:

Gastrointestinal obstruction or carcinomatosis peritonei
CNS metastasis or disability in CNS
Intractable medical illness
Pregnancy or inadequate contraception

Sites / Locations

Chonnam National University Hwasun Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Ramosetron 0.6mg

Ramosetron 0.45mg

Ramosetron 0.3mg

Arm Description

Ramosetron 0.6mg intravenous injection 30min before chemotherapy

Ramosetron 0.45mg intravenous injection 30min before chemotherapy

Ramosetron 0.3mg intravenous injection 30 min before chemotherapy

Outcomes

Primary Outcome Measures

Pharmacokinetic profile of Ramosetron according to 3 level of dose

Pharmacokinectics using NONMEM will be analyzed from serum after Ramosetron injection from 10 min to 48 hours (10min, 1hr, 6hr, 24hr, 48hr)

Secondary Outcome Measures

Rhodes Index

Monitor using Rhodes Index will be performed each time at 1hour, 6hour, 24hour, 48hour and seven dyas after Ramosetron injection

Full Information

NCT ID

NCT02076529

First Posted

February 28, 2014

Last Updated

February 28, 2014

Sponsor

Chonnam National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02076529

Brief Title

Phamacokinetic and Pharmacodynamic Study of Ramosetron in Chemotherapy Induced Nasea and Vomiting

Official Title

A Study About Pharmacokinetic and Pharmacodynamics of Ramosetron in Chemotherapy Induced Nausea and Vomiting

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chonnam National University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is designted to know optimal dose of Ramosteron to control for chemotherapy induced nasea and vomoting (CINV)based on its pharmacokinetics, pharmacodynamic study and clinilcal parameters using Rhodes Index.

Detailed Description

Nausea and vomiting is a common adverse event during chemotherapy treatment. Even if preventive medicines such as dopamine receptor antagonist, corticosteroid, serotonin receptor antagonist, has been developed and used, there is residual nausea and/or vomiting in a significant percentage of patients treated for cancer. Serotonin receptor antagonist is the most potent antiemetic agent and has been used widely. However, the optimal dose of serotonin antagnosit based on individual symptoms is not defined. Therefore, this study was conducted to design standardization model for optiomal serotonin antagonist concentration using pharmacodynamic study and Rhodes Index as a suggogate marker for CINV.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colon Cancer

Keywords

chemotherapy induced nausea vomiting

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ramosetron 0.6mg

Arm Type

Experimental

Arm Description

Ramosetron 0.6mg intravenous injection 30min before chemotherapy

Arm Title

Ramosetron 0.45mg

Arm Type

Experimental

Arm Description

Ramosetron 0.45mg intravenous injection 30min before chemotherapy

Arm Title

Ramosetron 0.3mg

Arm Type

Active Comparator

Arm Description

Ramosetron 0.3mg intravenous injection 30 min before chemotherapy

Intervention Type

Drug

Intervention Name(s)

Ramosetron 0.3mg

Other Intervention Name(s)

Nasea 0.3mg

Intervention Type

Drug

Intervention Name(s)

Ramosetron 0.45mg

Other Intervention Name(s)

Nasea 0.45mg

Intervention Type

Drug

Intervention Name(s)

Ramosetron 0.6mg

Other Intervention Name(s)

Nasea 0.6mg

Primary Outcome Measure Information:

Title

Pharmacokinetic profile of Ramosetron according to 3 level of dose

Description

Pharmacokinectics using NONMEM will be analyzed from serum after Ramosetron injection from 10 min to 48 hours (10min, 1hr, 6hr, 24hr, 48hr)

Time Frame

10min to 48 hours post-dose

Secondary Outcome Measure Information:

Title

Rhodes Index

Description

Monitor using Rhodes Index will be performed each time at 1hour, 6hour, 24hour, 48hour and seven dyas after Ramosetron injection

Time Frame

1 hour to seven days post-dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients who recevied moderate emetogenic chemotherapy Age between 18-75 ECOG PS 0-2 Adequate organ fuction including bone marrow, liver and kidney Exclusion Criteria: Gastrointestinal obstruction or carcinomatosis peritonei CNS metastasis or disability in CNS Intractable medical illness Pregnancy or inadequate contraception

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sang-Hee Cho, M.D.Ph.D.

Organizational Affiliation

CNUHH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chonnam National University Hwasun Hospital

City

Gwangju

State/Province

Jeollanamdo

ZIP/Postal Code

519-809

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Phamacokinetic and Pharmacodynamic Study of Ramosetron in Chemotherapy Induced Nasea and Vomiting

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